Back to resultsImmunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
Primary Purpose
Pneumonia, Meningitis, Invasive Pneumococcal Disease
Status
Completed
Phase
Phase 4
Locations
Malawi
Study Type
Interventional
Intervention
7-valent pneumococcal conjugate vaccine (Prevnar)
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia focused on measuring Vaccine, Lung, Bronchoalveolar lavage, Lymphocyte, Immunoglobulin, HIV, Streptococcus pneumoniae, Conjugate vaccine
Eligibility Criteria
Inclusion Criteria:
- healthy volunteer adults
Exclusion Criteria:
- pregnant, recent illness, previous vaccination, asthma
Sites / Locations
- Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital
Outcomes
Primary Outcome Measures
Immunoglobulin titres in bronchoalveolar fluid
Secondary Outcome Measures
Immunoglobulin titres in serum
Lung lymphocyte phenotype
HIV viral load
Full Information
NCT ID
NCT00371878
First Posted
September 1, 2006
Last Updated
August 7, 2008
Sponsor
Royal Liverpool University Hospital
Collaborators
Kamuzu University of Health Sciences, Liverpool School of Tropical Medicine, Wellcome Trust
1. Study Identification
Unique Protocol Identification Number
NCT00371878
Brief Title
Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
Official Title
Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Liverpool University Hospital
Collaborators
Kamuzu University of Health Sciences, Liverpool School of Tropical Medicine, Wellcome Trust
4. Oversight
5. Study Description
Brief Summary
Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine.
Detailed Description
We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum. We further hypothesized that this response would be further compromised with HIV co-infection[32] due to lack of local CD4 lymphocyte support and an altered alveolar milieu. We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers, together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte, B lymphocyte and macrophages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Meningitis, Invasive Pneumococcal Disease, HIV
Keywords
Vaccine, Lung, Bronchoalveolar lavage, Lymphocyte, Immunoglobulin, HIV, Streptococcus pneumoniae, Conjugate vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
7-valent pneumococcal conjugate vaccine (Prevnar)
Primary Outcome Measure Information:
Title
Immunoglobulin titres in bronchoalveolar fluid
Secondary Outcome Measure Information:
Title
Immunoglobulin titres in serum
Title
Lung lymphocyte phenotype
Title
HIV viral load
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteer adults
Exclusion Criteria:
pregnant, recent illness, previous vaccination, asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil French, PhD FRCP
Organizational Affiliation
Karonga Prevention Study, London School of Tropical Medicine and Hygience
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephen B Gordon, MA MD FRCP
Organizational Affiliation
Liverpool School of Tropical Medicine, Liverpool, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital
City
Blantyre
ZIP/Postal Code
BT3
Country
Malawi
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
We'll reach out to this number within 24 hrs